510(k) K012530
- Device
- AA-1 SYSTEM
- Applicant
- NEUROVISION, INC.
- 510(k) number
- K012530
- Product code
- HJT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-08-31
- Date received
- 2001-08-06
- Regulation
- 886.1340
- Classification name
- Haploscope
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD E LIPPMAN
- Address
- 12300 Twinbrook Pkwy. Suite 230 Rockville MD US 20852 20852
FDA Registration Numbers#
- 3006563559
- 3005641619
- 3018064256
- 3004574050
- 3014400613
- 3012185572
- 3042228518
- 3015867300
Source Documents#
Other 510(k) Records For Product Code HJT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K013110 | ANISEIKONIA INSPECTOR | Optical Diagnostics, Inc. | 2001-12-19 |
Legacy Summary#
summary
FDA Review#
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